Delaying Approval of a Critical Drug: Safety, Efficacy, Economics, Compassion
Rosenberg, Leo T.
JOURNAL OF MEDICAL HUMANITIES 1994 Winter; 15(4): 243-250
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Rosenberg, Leo T. (1994)Biotechnological advance is speeding the development of drugs. The approval processes for new drugs will inevitably involve a regulatory agency in making political-economic and scientific choices. Interests of specific patients ...
A Bill to Amend the Federal Food, Drug and Cosmetic Act to Provide for a Federal Drug Compendium Which Provides Reliable, Complete, and Readily Accessible Prescribing Information; to Assure Safety and Efficacy of Drugs Through Certification Of Certain Drugs Other Than Insulin and Antibiotics; to Require Certain Information in Drug Labeling; and to Improve the Administration and Enforcement of the Act as It Relates to Drugs Unknown author (United States. Congress. Senate, 1979)